A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication

This study is currently recruiting participants.

Verified by University of Colorado, Denver, June 2007

First Received: June 5, 2007 No Changes Posted

Sponsor:	University of Colorado, Denver
Collaborators:	The Miriam Hospital University of Washington Bristol-Myers Squibb
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00482963

Purpose

The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.

Condition	Intervention	Phase
HIV Infections Contraception Pharmacokinetics	Drug: levonorgestrel, efavirenz	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz

Resource links provided by NLM:

MedlinePlus related topics: AIDS Birth Control

Drug Information available for: Efavirenz Levonorgestrel

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz [ Time Frame: 12 hour pharmacokinetic study ]

Secondary Outcome Measures:

Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz [ Time Frame: 12 hour pharmacokinetic study ]
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz [ Time Frame: 3 weeks ]
Changes in liver function tests before and during efavirenz [ Time Frame: 3 weeks ]
The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls [ Time Frame: 12 hour pharmacokinetic study ]

Estimated Enrollment:	24
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2008

Detailed Description:

The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, HIV-1 seronegative women of child-bearing age.

Exclusion Criteria:

Current use of hormonal contraception
Pregnancy/Breast Feeding
Post-menopausal status
Obesity
Hepatitis B or C
Psychiatric illness
Active Substance Abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482963

Locations

United States, Colorado
University of Colorado Health Sciences Center	Recruiting
Denver, Colorado, United States, 80262
Contact: Monica L Carten, MD 720-848-0819 monica.carten@uchsc.edu
Principal Investigator: Monica L Carten, MD
Sub-Investigator: Stephanie Teal, MD, MPH
United States, Rhode Island
The Miriam Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Deborah K Perez 401-793-4632 dperez@lifespan.org
Principal Investigator: Awewura Kwara, MD
Sub-Investigator: Susan Cu-Uvin, MD

Sponsors and Collaborators

University of Colorado, Denver

The Miriam Hospital

University of Washington

Bristol-Myers Squibb

Investigators

Principal Investigator:

Monica L Carten, MD

University of Colorado, Denver

More Information

No publications provided

Study ID Numbers:	06-1178
Study First Received:	June 5, 2007
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00482963 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:

HIV
Contraception
Antiretroviral agents
Pharmacokinetics

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Disease Attributes
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Reproductive Control Agents
Infection
Reverse Transcriptase Inhibitors
Pathologic Processes
Anti-Retroviral Agents
Levonorgestrel

Therapeutic Uses
Contraceptives, Oral, Synthetic
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections

ClinicalTrials.gov processed this record on February 08, 2010